Sr. GMP Technician
2 days ago
Rahway
Job details Kelly Science and Clinical FSP is currently seeking a Sr. GMP Technician for a long-term engagement in Rahway, NJ with one of our Global Pharmaceutical clients. This position is onsite. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time. Senior GMP Technician General Requirements • Following local procedures, • Completing required training, • Adhering to GMP requirements for documentation of activities, • Cleaning, sanitizing, and breaking down equipment, • High School Diploma, • Prepare the appropriate disinfectants as per SOP., • Understand the dwell time for all cleaning agents/chemicals., • Cleaning of the processing rooms following manufacturing processes and as required per procedure. Remove all trash/biohazard waste bags from the MFG area., • Stocks all gowning materials in all air locks and locker rooms., • Execute cleaning of major and minor pieces of equipment and ancillary equipment, • Disassembly and reassembly of equipment per procedure (as required), • Perform cleaning activities on the isolators and filling line, • Perform cleaning verification activities to support cleaning validation, • Accurately documenting activities in the appropriate logbooks., • Able to work with a respirator during special assignments, if required., • Maintain materials inventory., • Report any unexpected observations to area management., • Perform tasks under minimal supervision, and within tight timelines to meet production schedule., • Coordinate with engineers & maintenance personnel in facility upkeep, • Author and revise SOPs and logbooks., • Good interpersonal skills and attention to detail., • Previous experience in cleaning the GMP area is required., • Must be able to follow GMP regulations during operations, including adherence to written procedure and contemporaneous documentation., • Must be able to record data accurately and legibly., • Physically capable of donning and wearing cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees, • Perform operations within ISO Class clean rooms, • Employees must be able to lift and/or move up to 40 pounds, • Must be able to squat, bend, kneel, and or reach for 40% of a shift